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An AAMI Webinar:
Labeling and Labeling Controls
Speakers: Arthur J. Ward, PhD
Christine Nelson
November 16, 2010 11:00 am – 1:00 pm EST
10:00 am – 12:00 pm CST 9:00 am – 11:00 am MST 8:00 am – 10:00 am PST
16:00 – 18:00 GMT
Presented by:
Association for the Advancement of Medical Instrumentation
The Association for the Advancement of Medical Instrumentation (AAMI) has granted permission to the program speakers to quote from standards produced and published by AAMI. Views expressed by the speakers herein do not represent the views of AAMI or any AAMI Standards Committee or U.S. Technical Advisory Group administered by AAMI. Information concerning the content of draft standards that speakers may include within these materials is subject to change as a result of ballot and public review. Therefore, the content of a final standard could differ significantly from the content of its draft version. AAMI is a not-for-profit association whose programs include the development of voluntary consensus standards for medical devices, and educational programs about medical devices for the healthcare community. AAMI does not test or otherwise evaluate specific products or services, endorse specific products or services, or attempt to monitor claims by manufacturers or consumers that certain products or services meet, or do not meet, AAMI standards.
AAMI’s STATEMENT OF QUALITY EDUCATION The Association for the Advancement of Medical Instrumentation (AAMI) strives for the highest possible standards in its educational resources and programs. AAMI endeavors to offer timely, practical, innovative, and visionary educational opportunities so that individuals will be knowledgeable in medical device management, regulation, and standards, equipped with the tools necessary for effective and informed decision making, and recognized as an integral part of healthcare delivery worldwide. GUIDING PRINCIPLES Excellence: AAMI believes that excellence in education is fundamental to safe and effective design, production, and use of medical devices, essential to the pursuit of new innovations, and central to the assurance of positive healthcare outcomes for all individuals. Fair Balance: AAMI maximizes fair balance in its educational programs in order to provide multiple perspectives from which its members can form professional opinions and become valuable resources in the healthcare continuum. Integrity: AAMI seeks to maintain the respect of all healthcare professionals, faculty members, students, and others by constantly improving its educational programs, by providing the best educational services available, and by maintaining a professional and positive learning environment. Value: AAMI strives to make high quality, accessible, and affordable education programs a top priority. Collaboration and Cooperation: AAMI believes that a collaborative learning environment encourages communication among colleagues and contributes to the fulfillment of professional and personal educational goals. To this end, AAMI seeks ways to foster interaction among its members and others by optimizing opportunities for sharing ideas and exchanging valuable information and knowledge. Responsibility: AAMI accepts its responsibility to contribute not only to the on-going learning of the medical device industry and individual healthcare technology managers and operators, but to the enrichment and advancement of the healthcare system. Through a commitment to offering excellent educational programs, it is AAMI’s goal to help its members exceed the expectations of those they serve and to improve patient outcomes. Leadership: By occupying a position of unique leadership in education, AAMI members and all others who participate in its educational programs will meet new challenges with creative solutions, face new questions with in-depth knowledge, and embrace new opportunities with unbridled and open-minded enthusiasm.
Labeling and Labeling Controls
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Labeling and Labeling Controls
Labeling and Labeling Controls
November 16, 2010Presented by
Association for the Advancement of Medical Instrumentation
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Speakers
Arthur J. Ward, PhD - Medical Device Consultant, AJW Technology Consultants Inc.
Christine Nelson - Trainer/Consultant
Labeling and Labeling Controls
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Webinar CD
Would you like the ability to refer back to the information presented during today’s webinar at a later date?
Or, do you know of someone who couldn't participate in the webinar but would find the materials presented informative and useful?
CDs of the program will be available for shipment in three weeks. To purchase, please visit http://aami.confedge.com/asset/confEdge/aami/_warehouse/files/CDOrderFormLLCWCD.pdf
$295 for webinar registrants $395 for non-registrants
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Handouts
To download the slides presented during the webinar, please go to: http://aami.confedge.com/ap/eSite/?i=Labeling
Labeling and Labeling Controls
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Audience Composition
We will now poll the audience to determine how many people are joining us today. Please enter the number of people at your site in the text box on your screen.
Labeling Controls
Training Program
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Labeling and Labeling Controls
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Labeling Objectives
Review key definitionsProvide an overview of labeling regulations
21 CFR 80121 CFR 82021 CFR 809
Review key labeling controlsSelected review of labeling guidance
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Definitions – From Food, Drug, & Cosmetic Act
Labels – a display of written, printed or graphic matter upon the immediate container of an article
Labeling and Labeling Controls
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Definition
Labeling – all labels and other written, printed or graphic materials
On an article or its containers or wrappersAccompanying such article at any time….
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Labeling Applies to…
Labels on productsLabeling accompanying products
InsertsUser manualService manualPatient guides
Labeling and Labeling Controls
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Labeling Applies to…
Labeling about productsBrochures LiteratureWeb siteExhibition materialOral communication
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Labeling Regulations
21 CFR 80121 CFR 809 (In Vitro Diagnostics)21 CFR 820
Labeling and Labeling Controls
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Labeling Regulations
21 CFR 801
Labeling for Medical Devices
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Primary Requirements
21 CFR 801.1Label must display
Manufacturer’s nameCity and stateFull address if not listed in city directory
Labeling and Labeling Controls
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Primary Requirements
21 CFR 801.1If the device is not manufactured by firm then include statements like
Manufactured for, orDistributed by
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Primary Requirements
21 CFR 801.4Intended use is shown by
Labeling claimsAdvertisingWritten or oral statements by firm or their representatives
Labeling and Labeling Controls
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Primary Requirements
21 CFR 801.5Directions for use must be adequate for the layman using device (which may be a medical professional) and include:
Normal dosageFrequency of administrationDuration of applicationTime of administration in relation to symptomsMethod of administrationPreparation for useTemperature or other adjustment
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Primary Requirements
21 CFR 801.15All required statements must be sufficient in size and space to be properly conspicuousLabel space allocated must be adequate to fit all required information
Labeling and Labeling Controls
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Primary Requirements
21 CFR 801.60Over-the-counter labeling
Provides for numerous principal panel display requirements depending on the shape of the package (e.g., cylindrical or rectangular)
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Primary Requirements
21 CFR 801.109-.150Labeling exemptions
For particular reasons citedFor commonly known devicesFor IVD devices if they comply with 21 CFR 809.10
Labeling and Labeling Controls
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Primary Requirements
21 CFR 801.405-.437Special labeling requirements
Hearing aidsTamponsCondomsNatural rubber productsDentures
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Primary Requirements
21 CFR 809
In Vitro Diagnostic Products for Human Use
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
21 CFR 809.10 – a specific regulation for labeling of IVD productsSpecial sections for both instruments and reagents
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagents include:
Established or common nameNet quantity in volumes or weight, etc.Quantity or concentration of reactive ingredientMeans for user to be assured of its purity or quality at time of use
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagents include:
Statement of intended useManufacturer’s name and addressLot number or control numberExpiration dateStorage instructions
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagents include:
Statements of user warning and precautions per 16 CFR 1500A statement: “For In Vitro Diagnostic Use”Any reconstitution instructions needed
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Additional requirements for instruments include:
Serial or control number that will permit tracing to identify all function assembliesFor multiple-unit products that must be used together as a system, a way to link all of the suitable identification information
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagent packaging inserts include:
Proprietary name and common nameIntended use and type of procedureSummary and explanation of the testChemical, physical or biological principles of the procedure
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagent packaging inserts include:
Warnings and precautionsInstructions for reconstitution, mixing, etc.Storage instructionsAny purification or treatment needed before use
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for reagent packaging inserts include:
Physical, biological or chemical indications of instability or deteriorationA statement: “For In Vitro Diagnostic Use”
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts or manuals include:
Statement of use or functionInstallation proceduresOperating principlesPerformance characteristics and specifications
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts include:
Operating instructionsCalibration proceduresHazards and operational precautionsService and maintenance informationSpecimen collection and preparation
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts include:
Precautions for specimen collection and need for additives, etc.Information on known interfering substancesSpecimen storage and handling instructionsA step-by-step procedure outline
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts include:
A list of materials provided and those also neededThe amount of reagent necessary with detailed information on its useStatement of the stability of the final reaction
Labeling and Labeling Controls
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts include:
Instrument calibration detailsQuality control procedures and use of negative and positive controlsMethod for calculating the unknown resultLimitations and expected values
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Primary Requirements –In Vitro Diagnostics
Some of the requirements for instrument packaging inserts include:
Specific performance characteristicsBibliography for referenceManufacturer’s name and locationDate of issuance of the last labeling revision
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820
Quality System Regulation
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Primary Requirements
21 CFR 820.3jDevice Master Record definition:
Compilation of records containing procedures and specifications for a finished device
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.181Device Master Record
Includes all labels in the device or its packagingIncludes all labeling “accompanying” device (whether electronic or printed)
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Primary Requirements
21 CFR 820.120 – Device LabelingIntegrityInspectionStorageOperations
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.120aLabeling controls - integrity
LegibilityRemain affixed
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Primary Requirements
21 CFR 820.120bLabeling controls - inspection
Performed before storage or use by a designated individualDocumented including release date and signature
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.120bLabeling inspection
Includes – label accuracyCorrect expiration dateControl number Special storage instructionsHandling instructionsAdditional processing instructions
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Primary Requirements
21 CFR 820.120cLabeling controls - storage
All labels stored • Properly identified• Prevent mix ups
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.120dLabeling controls - operations
Control labeling to prevent mix-ups (line clearance is a method)Labels and labeling used must be recorded in DHR
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Primary Requirements
21 CFR 820.120eLabel control number
When device requires a control number or you assign one, the control number must be legible and accompany device through distribution
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.3(g) – Design OutputProduct specifications are the design outputDesign output consists of
A device LabelingPackaging Device master record
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Primary Requirements
21 CFR 820.3iDevice History Record – definition
Compilation of records containing production history for a finished device
Labeling and Labeling Controls
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Primary Requirements
21 CFR 820.184Device History Record must include
Date manufacturedQuantity manufactured and quantity releasedAcceptance records showing device made per DMRPrimary identification labelOther labeling used for each deviceDevice identification and control number
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Labeling Practices
Assign each label/labeling item a distinct part numberHave approved labeling masters by revisionControl any changes via formal ECO process
Labeling and Labeling Controls
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Labeling Practices
Purchased labelingQualify supplier on approved vendor listApproved specification sent to supplierUse purchase order processIncoming inspectionInspection recordsStorage and warehouse controls
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Labeling Practices
Internal printed labelingUse approved specificationEquipment qualificationSoftware validationProcess validation (if applicable)Formal inspection that is documented
Labeling and Labeling Controls
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Labeling Practices
Labeling issued by work orderLabels counted when issuedFormal line clearance between production lots or work ordersOnce a lot is completed account for unused labels
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Labeling Practices
Device History Record – by lotAttach primary identification label/copyRecord all other labeling in DHRIf batch includes multiple serial numbers
Copy first and last or write in serial number range
Labeling and Labeling Controls
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Guidance Information
FDA has issued a number of Labeling Guidances, and these are just a select few to review
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E-Labeling
FDA Guidance dated March 31, 2003Blue Book Memorandum # G03-1
Permits e-labeling for all professional productsHard copy of all labeling must be made available on requestE-labeling is not permitted for non-professional products, i.e., home use
Labeling and Labeling Controls
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E-Labeling
A link to the FDA E-Labeling Guidance may be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109200
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Symbols for IVD Labeling
FDA Guidance dated November 30, 2004FDA recognized a series of symbols that may be used on IVD productsThe Guidance provides a copy of each of the allowed symbols and their definition
Labeling and Labeling Controls
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Symbols for IVD Labeling
A link to the FDA IVD Symbol Labeling Guidance may be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm
Other than this Guidance there is currently minimal recognition of symbols by FDA
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Adding URLs to Electronic Products
FDA Guidance dated September 30, 2010FDA is encouraging the addition of Uniform Resource Locators on all electronic productsAlso the inclusion of the firm’s
Full nameAddressMonth and year of product manufacture
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Adding URLs to Electronic Products
A link to the FDA URL Labeling Guidance may be found at:http://www.fda.gov/MedicalDevices/DeviceR
egulationandGuidance/GuidanceDocuments/ucm228553.htm
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Labeling Summary
Prepared per the applicable regulation(s) and GuidanceSpecified in DMRInspectedControlledDocumented in DHR
Labeling and Labeling Controls
To submit a question, please type your question in the “Chat (Q&A)” box on the left side of your screen and press Enter, or press *1 on your telephone keypad.
Questions?
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Closing Reminders
• Please be sure to fill out the evaluation form after the webinar. If you have additional comments, please contact Emilee Hughes at (703) 253-8278 or ehughes@aami.org.
• CDs of this program will be available for shipment in three weeks. To purchase, please visit http://aami.confedge.com/asset/confEdge/aami/_warehouse/files/CDOrderFormLLCWCD.pdf.• $295 for webinar registrants • $395 for non-registrants
• Visit http://www.aami.org/meetings/webinars/ to learn about AAMI’s future webinar events. Upcoming programs include:• ANSI/AAMI ST79 Steam Sterilization Update• Joint Commission Activities Impacting Biomedical and Clinical Engineering
Departments • AAMI/IEC 80001-1 - Risk Management for IT Networks
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